Does “federal law, which imposes a strict set of labeling requirements on manufacturers of Final Monograph [Over-the-Counter (‘OTC’)] drugs, including mandatory product warnings authored by the FDA, [preempt] state-law product liability actions premised on theories of failure to warn[?]” That is the question posed by McNeil-P.P.C., Inc. (“McNeil”) in a recent Petition for Writ of Certiorari filed with the U.S. Supreme Court.

The petition stems from the tragic events of April 24, 1999, when 16-year old Armando Valdes, III collapsed during a roller hockey game. Armando allegedly consumed McNeil’s OTC drug Tylenol Cold (and/or Tylenol Flu) containing pseudoephedrine for a head cold, along with a caffeinated beverage, the morning of the roller hockey game. Doctors diagnosed Armando with having suffered a heat stroke and cardio-respiratory arrest which resulted in a brain injury, hypoxic ischemic encephalopathy, and left Armando completely disabled.

Armando and his parents filed a negligence and products liability suit against McNeil (as well as the hockey club and equipment vendor, which settled with the Valdes family) for Armando’s injuries. They contend that McNeil’s product “increased the risk of heat-related illness and heart-related risks when ingested with caffeinated products and coupled with strenuous or athletic events in a hot environment like that of South Florida,” and asserted that McNeil’s failure to warn of these risks breached Florida state law requirements.

McNeil asserted, among other affirmative defenses, federal preemption. After discovery, McNeil moved for final summary judgment on federal preemption grounds – specifically, that “federal law, which governs [OTC] and non-prescription drugs, and the FDA’s labeling requirements, which did not require McNeil to include the risk of heat-related illness on the label, preempted the state law claims in the Valdeses’ complaint.” The Circuit Court for Miami-Dade County agreed with McNeil and granted final summary judgment, finding that “implied conflict pre-emption applied because it would have been impossible for McNeil to comply with federal regulations that mandate the exact warnings for labels of all OTC pseudoephedrine-containing products (including those sold by McNeil) while also meeting state common law jury determinations of whether the FDA-crafted warnings were adequate.” The Valdeses appealed the decision to the Third District Court of Appeal of Florida.

In December 2009, the Third District Court of Appeal of Florida reversed the final summary judgment for McNeill on the basis that the U.S. Supreme Court’s March 2009 decision in Wyeth v. Levine “controls the issue of federal preemption presented in this case.” (In Wyeth, the Court ruled, by a 6-3 vote, in the context of a brand-name prescription drug, that FDA labeling approval does not preempt state laws.) Although McNeil argued that Wyeth is distinguishable because it dealt with prescription drugs and not OTC drugs, the court disagreed with McNeil that “the distinction carries the weight to allow it to circumvent the reasoning of the Court in Wyeth.” McNeil sought discretionary review of the Third District Court of Appeal’s decision by the Supreme Court of Florida; however, that petition was denied on August 2, 2010.

McNeil’s November 30, 2010 petition argues that the Court should grant review to “correct” Florida’s rejection of impossibility conflict preemption in a case where the law does not contain a provision permitting a manufacturer to unilaterally change its product labeling by adding a warning. (Although we note that there are procedures to amend an OTC drug monograph). According to McNeil:

In rejecting Wyeth's implied conflict preemption argument, this Court relied on specIfic statutes and regulations applicable to manufacturers of brand-name prescription drugs, which allow the manufacturer to strengthen product warnings without prior FDA approval, pursuant to a "changes being effected" ("CBE") procedure. The appellate court in Valdes ignored the fact that prescription and OTC drugs are subject to differnt federal regulatory regimes. The appellate court failed to recognize that federal laws applicable to manufacturers of OTC products do not provide a mechanism similar to the CBE procedure that would permit a manufacturer to unilaterally change the warnings on product labeling crafted by the FDA.

Under FDA’s regulations at 21 C.F.R. Part 330, OTC drug labeling “shall be stated in the exact language where exact language has been established and identified by quotation marks in an applicable OTC drug monograph regulation.” In addition, FDC Act § 751 (National Uniformity for Nonprescription Drugs) provides that in general “no State or political subdivision of a State may establish or continue in effect any requirement” for an OTC drug “that is different from or in addition to, or that is otherwise not identical with, a requirement under [the FDC Act], the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).”

In addition to the Florida court reading Wyeth “so broadly as to preclude the assertion of implied conflict pre-emption based on impossibility under any circumstances,” McNeil notes that Wyeth has been misapplied by other courts in the OTC drug context. For example, McNeil cites the Seventh Circuit Court of Appeals’ August 2010 decision in Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. 2010) concerning the preemptive effect of FDA’s decision not to add a warning to Children’s Motrin. In that decision, Judge Posner cited Wyeth for the proposition that courts are free to hold “that state law requires warnings on the label of an [OTC] drug beyond what the FDA has required.”

“Without preemption,” McNeil states, “OTC drug manufacturers would be deprived of the ability to rely on FDA’s directives as to matters that Congress delegated to the Agency and that fall within the Agency’s unique regulatory and scientific expertise.” In addition, “[w]ithout pre-emption, McNeil, and all other OTC drug manufacturers, would be deprived of the ability to comply simultaneously with their federal and state obligations or even to ascertain what those obligations are without resort to litigation.”